Company
ChinaBIOXIN MEDICAL CO., LTD, Weihai, China – FDA Inspections
Inspection records and compliance data for BIOXIN MEDICAL CO., LTD in Weihai. 1 FDA inspection on record, 1 Form 483, last inspected April 04, 2019.
Company Profile
This profile covers BIOXIN MEDICAL CO., LTD based in Weihai, China.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected April 4, 2019.
Most cited issue areas
- Documentation of validated process performance1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Product rework documentation, DHR {see also 820.184}1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 4, 2019 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1086439 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
BIOXIN MEDICAL CO., LTD
FEI Number
3008496528
Address
No.288-7/288-13, Shanhai Road, Torch Hi-tech Science Park, Weihai, China
Country
China
ID: e5500850-cb1f-4947-96db-ca493f94e327